The objective of this study is to evaluate the efficacy, pharmacokinetics, pharmacodynamics and safety of ASP1707 in combination with MTX in postmenopausal female patients with RA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Oral
Oral
Methotrexate will be orally administered at stable dose from at least 28 days prior to screening through the screening and treatment periods until the end of the follow-up period.
Site JP00004
Numakunai, Iwate, Japan
Site JP00005
Numakunai, Iwate, Japan
ACR20 response rate
ACR20: American College of Rheumatology 20
Time frame: Week 12
ACR20 response rate
Time frame: Up to Week 8
ACR50 response rate
Time frame: Up to Week 12
ACR70 response rate
Time frame: Up to Week 12
Change from baseline in DAS28-CRP score
DAS28-CRP: Disease Activity Score28 - C-reactive protein
Time frame: Baseline and Up to Week 12
Change from baseline in DAS28-ESR score
DAS28-ESR: Disease Activity Score28 - Erythrocyte sedimentation rate
Time frame: Baseline and Up to Week 12
Change from baseline in Tender Joint Count (68 joints)
Time frame: Baseline and Up to Week 12
Change from baseline in Swollen Joint Count (66 joints)
Time frame: Baseline and Up to Week 12
Percentage of subjects achieving DAS28-CRP score and DAS28-ESR score for remission (<2.6)
Time frame: Up to Week 12
Percentage of subjects achieving DAS28-CRP score and DAS28-ESR score for low disease activity (≤3.2)
Time frame: Up to Week 12
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Site JP00022
Aichi, Japan
Site JP00023
Aichi, Japan
Site JP00017
Chiba, Japan
Site JP00026
Ehime, Japan
Site JP00025
Fukui, Japan
Site JP00012
Fukuoka, Japan
Site JP00018
Fukuoka, Japan
Site JP00019
Fukuoka, Japan
...and 17 more locations
Change from baseline in CRP
Time frame: Baseline and Up to Week 12
Change from baseline in ESR
Time frame: Baseline and Up to Week 12
Percentage of subjects achieving EULAR response criterion of "Good Response"
EULAR: European league Against Rheumatism
Time frame: Up to Week 12
Percentage of subjects achieving EULAR response criterion of "Good Response" or "Moderate Response"
Time frame: Up to Week 12
Percentage of subjects achieving ACR/EULAR score for remission
Time frame: Up to Week 12
Percentage of subjects achieving SDAI score ≦ 3.3 (SDAI remission)
SDAI: Simplified Disease Activity Index
Time frame: Up to Week 12
Change from baseline in the SDAI score
Time frame: Baseline and Up to Week 12
Change from baseline for the HAQ-DI
HAQ-DI: Health Assessment Questionnaire - Disability Index
Time frame: Baseline and Up to Week 12
Safety assessed by incidence of adverse events
Time frame: Up to Week 13
Safety assessed by body temperature
Time frame: Up to Week 13
Safety assessed by pulse rate
Time frame: Up to Week 13
Safety assessed by blood pressure in sitting position
Time frame: Up to Week 13
Safety assessed by laboratory tests: Hematology
Time frame: Up to Week 13
Safety assessed by laboratory tests: Biochemistry
Time frame: Up to Week 13
Safety assessed by laboratory tests: Urinalysis
Time frame: Up to Week 13
Safety assessed by standard 12-lead electrocardiogram
Time frame: Up to Week 13
Safety assessed by weight
Time frame: Up to Week 13
Plasma concentration of ASP1707
Time frame: Up to Week 12
Plasma concentration of metabolite of ASP1707
Time frame: Up to Week 12
Pharmacodynamics assessed by endocrinology tests
Time frame: Up to Week 13
Pharmacodynamics assessed by plasma concentration of TNF-α
TNF: Tumor Necrosis Factor
Time frame: Up to Week 13
Pharmacodynamics assessed by plasma concentration of MMP3
MMP3: Matrix metalloproteinase 3
Time frame: Up to Week 13
Pharmacodynamics assessed by plasma concentration of IL-6
IL-6: Interleukin-6
Time frame: Up to Week 13